Comments of the New York Civil Liberties Union in regard to New York State Department of Health Proposed Rule Making: Amendments of Part 23 of Title 10 NYCRR January 11, 2016

The New York Civil Liberties Union (NYCLU) is grateful for the opportunity to provide comments to the Department of Health Proposed Rule Making regarding the Amendments of Part 23 of Title 10 of the New York Codes, Rules & Regulations (NYCRR), clarifying minors’ legal ability to consent to confidential testing and treatment for Sexually Transmitted Infections (STIs), including the vaccine for the Human Papillomavirus (HPV). The NYCLU, a nonprofit, nonpartisan organization with eight chapters and regional offices and nearly 50,000 members across the state, works to defend and promote the fundamental principles, rights and constitutional values embodied in the Bill of Rights of the U.S. Constitution and the Constitution of the State of New York. This includes the rights of privacy and personal autonomy that form the foundation of an individual’s right to receive confidential reproductive and sexual health care. In addition, as a matter of sound public health policy, privacy and confidentiality are essential for making informed and healthy medical decisions – particularly for those seeking sensitive health care services. The NYCLU applauds the department for clarifying these rights through its proposed regulation and recommends two modifications to further clarify the scope of medical care available to minors during health care visits. New York Public Health Law § 2305 and New York State Public Policy Permit Minors to Consent on Their Own to Receive the HPV Vaccine New York State law and policy already provide authority for minors to consent on their own to the provision of medical treatment, such as vaccines, that prevents sexually transmitted infections.1 New York Public Health Law § 2305(2) provides that a health care provider “may diagnose, treat or prescribe for a person under the age of twenty-one years without the consent or knowledge of the parents or guardian of said person, where such person is infected with a sexually transmissible disease, or has been exposed to infection with a sexually transmissible disease.” Because HPV is a “sexually transmitted disease,” because sexually active minors have been exposed, and because the HPV vaccine is a treatment, health care providers may provide it without parental consent under the statute. § 2305(2) is consistent with New York State public policy that seeks to encourage access to services related to reproductive and sexual health by keeping those services confidential. Under New York’s public health law, minors can consent on their own to abortion services and other health care related to pregnancy without parental consent.2 These statutes reflect a recognition of the importance, from a public health perspective, of providing minors with unimpeded access to these critical services, and further, are grounded in data that support the critical connection between confidentiality and improved access to care. Indeed, many minors will not seek sexual health care services if confidentiality is compromised.3 And in some circumstances, parental involvement results in harm to individual minors.4 The same concerns that animate the various statutory exceptions permitting minors to access certain types of care on their own apply equally in the case of inoculation against HPV. Minors may fear that their parents will find out they have received the vaccine (and/or that they have received other confidential services related to reproductive and sexual health), and that they will suffer harmful consequences due to their parents’ discovery that they are or will soon become sexually active. Minors should not be deterred from receiving this potentially life-saving treatment because of such fears. The Risk of Harm is Grave; but Prevention is Possible and Safe HPV is the most common sexually transmitted infection: in 2013, the Centers for Disease Control and Prevention (CDC) estimated that 79 million Americans are infected with HPV, 14 million people become newly infected each year, and virtually all sexually active people are infected with HPV at some point in their lifetime.5 And some strains of HPV are deadly. HPV causes almost all cases of cervical cancer worldwide, 85% of all anal cancer cases, close to half of vaginal, vulvar, and penile cancers, and 70% of oropharyngeal cancers (cancers of the throat, including soft palate, tongue, and tonsils).6 In the United States, about 12,900 new cases of invasive cervical cancer will be diagnosed this year and 4,100 women will die from cervical cancer.7 Two HPV strains (16 and 18) in particular are linked to 70% of all cervical cancer cases, and two other strains (6 and 11) are linked to 90% of cases of genital warts.8  Fortunately, HPV can be prevented. There are currently two available HPV vaccines: Merck’s Gardasil and GlaxoSmithKline’s Cervarix. Gardasil protects against four strains of the virus.9 Approved for use in women and men ages 9-26, Gardasil has been proven 100% effective in preventing the strains that cause cervical cancer, and 99% effective in preventing the strains that cause genital warts.10 Cervarix prevents two strains of HPV, 16 and 18.11  The vaccines have not only proved to be effective, but safe as well. As of 2012, more than 46 million doses of the HPV vaccine have been distributed in the United States.12 The FDA and CDC closely monitor the safety of all vaccines through the Vaccine Adverse Event Reporting System (VAERS).13 Through this system, the FDA and CDC have continually found that the benefits of the HPV vaccine far exceed any risk. 14 Indeed, studies of HPV vaccines involving thousands of people in many countries around the world, including the United States, have found that HPV vaccines are safe. 15  Amendments of Part 23 of Title 10 NYCRR Clarifies Minors’ Ability to Consent on Their Own and Receive the HPV Vaccine Confidentially The NYCLU applauds the department for clarifying sexually active minors’ ability to consent to the HPV vaccine and receive it confidentially. This critical clarification will increase the rates of young people who are protected against HPV and the risk of cancer. As previously discussed, New York Public Health Law § 2305(2) allows minors who have been exposed to a STI to consent to confidential STI testing or treatment, including the HPV vaccine, during health care visits. In the context of HPV, exposure is not limited to a narrow set of sexual activities, but includes skin to skin contact, kissing and oral sex.16 We applaud the department for making explicit in the proposed regulation and supporting guidance that providers may administer the HPV vaccine to minors who have been exposed when they seek out health care services. Further, the rule’s strong language regarding the confidentiality of minors’ medical and billing records ensures that sensitive information about minors’ confidential health care cannot be released without their permission.17  To ensure minors who may consent under the law benefit from Part 23’s guidance, the NYCLU makes two recommendations for further clarification. First, the NYCLU recommends the rule be clarified to allow minors who have been exposed to HPV to consent to the HPV vaccine regardless of the type of medical care initially sought. As proposed, the rule’s “Needs and Benefits” section states: “Section 23.4 permits health care providers to prescribe HPV vaccine to sexually active minors during a visit to diagnose and treat other STDs without consent or knowledge of the parent or guardian”(emphasis added).18 This statement seemingly attaches the provision of the HPV vaccine to medical visits where minors are specifically seeking testing or treatment for another STI. While it is unlikely the department intended this language narrowly, this apparent limitation is inconsistent with the language and purpose of the underlying statute and may ultimately prove confusing to some health care providers. Minors seek out confidential reproductive and sexual health care for many reasons, such as preventing pregnancy or questions related to sexual health often during a routine physical exam, and not solely for the testing and treatment of STIs. These visits provide a critical opportunity for health care providers to give information about and administer the HPV vaccine when a minor has been exposed to HPV. Thus, the department should clarify that the HPV vaccine may be provided to sexually active minors during the course of all confidential sexual and reproductive health care visits. Second, while it is apparent the department meant to allow health care providers to administer the HPV vaccine, the phrase found in the proposed rule’s “Needs and Benefits” section clarifies that providers may “prescribe” the HPV vaccine. 19 This too may prove confusing for providers who prescribe and administer the vaccine. Further, given that the HPV vaccine is medical treatment and well within the statute’s authorization, the department is not statutorily limited to using the term “prescribe.” Thus, the department should take this opportunity to clarify within the final rule that it meant to include administration of the vaccine as well. The NYCLU has long worked to secure and strengthen the fundamental right of privacy in making health-related decisions and receiving health care confidentially. For the foregoing reasons, the NYCLU supports the proposed rule, and further recommends clarification that minors who have been exposed to HPV may consent to the administration of the HPV vaccine during sexual and reproductive health care visits. We thank the department for the opportunity to provide comments on the proposed rule and look forward to seeing its swift implementation. These important clarifications will go a long way to preventing HPV and ensuring our young people have safe and healthy futures.

 

Footnotes 1 New York Public Health Law uses the term “sexually transmitted disease.” To reflect current medical terminology these comments use the term “sexually transmitted infection (STI)” except where referring specifically to language found in a statute or bill. For purposes of these comments, these terms mean the same thing. 2 See N.Y. Pub. Health Law §§ 2504, 2305 (McKinney 2006). 3  Studies have clearly shown that teens will simply not seek sexual health care services if their confidentiality is compromised. In a nationwide survey of students, the most common reason (35%) adolescents gave for failing to obtain needed health care was that they did not want a parent to know. Jonathan D. Klein et al., Access to medical care for adolescents: Results from the 1997 Commonwealth Fund Survey of the Health of Adolescent Girls, 25 J. of Adolescent Health 120 (1999). Further, a 2002 study in the Journal of the American Medical Association showed that almost half of sexually active teens visiting a family planning clinic would stop using clinic services if their parents were notified that they were seeking birth control, and another 11% reported that they would delay testing or treatment for STIs, including HIV. Notably, though, virtually all (99%) reported that they would continue having sex. D.M. Reddy et al., Effect of Mandatory Parental Notification on Adolescent Girls’ Use of Sexual Health Care Services, 288 JAMA 710 (2002); see also Carol A. Ford et al., Influence of Physician Confidentiality Assurances on Adolescents’ Willingness to Disclose Information and Seek Future Health Care, 278(12) JAMA 1029-34 (Sept. 1997) (finding that assurances of confidentiality increased adolescents willingness to return for a future visit from 62% to 72%); Tina L. Cheng et al., Confidentiality in Health Care, a Survey of Knowledge, Perceptions, and Attitudes Among High School Students, 269(11) JAMA 1404-07 (March 1993) (36% of kids with health concerns they wish to keep private would forgo healthcare if their parents might find out); T.M. Meehan et al., The Impact of Parental Consent on the HIV Testing of Minors, 87 Am. J. of Pub. Health 1338 (1997) (finding that that the number of adolescents tested for HIV in state-funded HIV testing centers in Connecticut doubled after parental consent requirements were removed, and visits and tests of high-risk minors in particular tripled). 4 Minors who do not wish to disclose to their parents that they are, or will soon become, sexually active often have good reasons, and threatening to compromise their confidentiality can have serious consequences. In one study, 30 percent of teens who did not tell a parent that they were pregnant feared physical violence between themselves and their parents (in many cases because it had already occurred) or being forced to leave home. Among minors whose parents found out about the pregnancy without being told by the minor herself, 58 percent reported one or more adverse consequences. Of those, a minimum of 6 percent suffered serious consequences, including physical violence at home, being beaten, or being forced to leave home. Eighteen percent said their parents were forcing them to have an abortion. These consequences were two to four times as common when the parents discovered the pregnancy as when they were told by their daughter herself. Stanley K. Henshaw and Kathryn Kost, Parental Involvement in Minors’ Abortion Decisions, 24 Fam. Plan. Persp. 196, 207 (1992). 5 Centers for Disease Control and Prevention, “Fact Sheet: Incidence, Prevalence, and Cost of Sexually Transmitted Infections in the United States,” Feb. 2013, available at http://www.cdc.gov/std/stats/sti-estimates-fact-sheet-feb-2013.pdf. 6 National Cancer Institute at the National Institutes of Health, “HPV and Cancer,” March 2012, available at http://www.cancer.gov/cancertopics/factsheet/Risk/HPV. 7 American Cancer Society, “Detailed Guide: Cervical Cancer: What Are the Key Statistics About Cervical Cancer?,” Feb. 2015, available at http://www.cancer.org/cancer/cervicalcancer/detailedguide/cervical-cance.... 8 “HPV and Cancer,” supra note 6. 9 United States Food and Drug Administration, “Gardasil Questions and Answers,” March 2014, available at http://www.fda.gov/BiologicsBloodVaccines/Vaccines/QuestionsaboutVaccine... Centers for Disease Control and Prevention, “Vaccine Information Statement for Gardasil,” May 2013, available at www.cdc.gov/vaccines/hcp/vis/vis-statements/hpv-gardasil.pdf; United States Food and Drug Administration, “FDA approves Gardasil 9 for prevention of certain cancers caused by five additional types of HPV,” Dec. 2014, available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm426485.htm. The FDA has also recently approved Merck’s Gardasil 9 for females ages 9 through 26 and males ages 9 through 15. Gardasil 9 protects against 5 additional HPV types in addition to those covered by the original Gardasil. 10 Supra note 9, “Gardasil Questions and Answers.” 11 Centers for Disease Control and Prevention, “Vaccine Information Statement for Cervarix,” May 2011, available at www.cdc.gov/vaccines/hcp/vis/vis-statements/hpv-cervarix.pdf. 12 Centers for Disease Control and Prevention, “HPV Vaccine Information for Clinicians - Fact Sheet,” July 2012, available at http://www.cdc.gov/std/hpv/stdfact-hpv-vaccine-hcp.htm. 13 See generally, The Vaccine Adverse Event Reporting System, available at http://vaers.hhs.gov/index. 14 Id.; Centers for Disease Control and Prevention, “Information from FDA and CDC on Gardasil and its Safety,” July 2008, available at http://www.cdc.gov/vaccinesafety/Vaccines/HPV/HPVArchived.html; Jay Gee et al., Division of Healthcare Quality and Promotion, Centers for Disease Control and Prevention, “Monitoring the safety of quadrivalent human papillomavirus vaccine: findings from the Vaccine Safety Datalink,” Oct. 2011, available at http://www.ncbi.nlm.nih.gov/pubmed/21907257 (a 38-month Vaccine Safety Datalink study of over 600,000 Gardasil vaccinations found no statistically significant difference in adverse effects from the Gardasil vaccine when compared to other vaccines). 15 Supra note 14, In the rare instance adverse effects have been reported in these studies, they are mild and include fever, dizziness, nausea, and pain at the site of the vaccination. 16 Centers for Disease Control and Prevention, “Human Papillomavirus (HPV)”, “HPV and Oropharyngeal Cancer - Fact Sheet”, “HPV and Men - Fact Sheet” available at: http://www.cdc.gov/hpv/parents/whatishpv.html and http://www.cdc.gov/std/hpv/stdfact-hpv-and-men.htm and http://www.cdc.gov/std/hpv/stdfact-hpvandoropharyngealcancer.htm. 17 New York State Department of Health, Proposed Rule Making: Amendments of Part 23 of Title 10 NYCRR (“23.4 Minors. When a health care provider diagnoses, treats or prescribes for a minor, without the consent or knowledge of a parent or guardian as permitted by section 2305 of the Public Health Law, neither medical nor billing records shall be released or in any manner be made available to the parent or guardian of such minor without the minor patient’s permission.”). 18 Id. (“Section 23.4 permits health care providers to prescribe HPV vaccine to sexually active minors during a visit to diagnose and treat other STDs without consent or knowledge of the parent or guardian.”). 19 Id.

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